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USPTO to Adjust Duty of Disclosure to Align With Therasense

In the wake of the Federal Circuit's 2011 decision in Therasense Inc. v. Becton Dickinson and Co., the USPTO quickly moved to revise the Duty of Disclosure to align with the Court's new, but-for materiality standard—perhaps too quickly. The 2011 proposal sought to update the relevant rules (1.56 and 1.555) by explicitly adding a short hand, reference to the Therasense case itself. The earlier proposal also intertwined the the "egregious conduct" exception of the Therasense holding (Duty of Candor & Good Faith) with the Duty of Disclosure.

At the time, I questioned whether it was unnecessarily confusing to mix together concepts of conduct and disclosure given the agency's historical segregation of such. Others found it odd that the rule would reference the name of the case as opposed to spelling out the "but-for" materiality standard of its holding.

Today, the USPTO has revisited this earlier proposal, and issued a new proposal.

The new proposal modifies Rules 56(a) for patent applications and Rule 555(a) for patent reexamination. The new proposal removes the explicit reference to Therasense, and adds in its place an explanation of but-for materiaility. The proposal also correctly separates the egregious conduct exception of Therasense from the Duty of Disclosure sections of these Rules (here).

The newly proposed Rule 56 is reproduced below:

§ 1.56 Duty to disclose information material to patentability.

(a) A patent by its very nature is affected with a public interest. The public interest is best served, and the most effective patent examination occurs when, at the time an application is being examined, the Office is aware of and evaluates the teachings of all information material to patentability. Each individual associated with the filing and prosecution of a patent application has a duty of candor and good faith in dealing with the Office, which includes a duty to disclose to the Office all information known to that individual to be material to patentability under the but-for materiality standard as defined in paragraph (b) of this section. The duty to disclose information exists with respect to each pending claim until the claim is cancelled or withdrawn from consideration or the application becomes abandoned. Information material to the patentability of a claim that is cancelled or withdrawn from consideration need not be submitted if the information is not material to the patentability of any claim remaining under consideration in the application. There is no duty to submit information which is not material to the patentability of any existing claim. The duty to disclose all information known to be material to patentability is deemed to be satisfied if all information known to be material to patentability of any claim issued in a patent was cited by the Office or submitted to the Office in the manner prescribed by §§ 1.97(b) through (d) and 1.98. However, no patent will be granted on an application in connection with which affirmative egregious misconduct was engaged in, fraud on the Office was practiced or attempted, or the duty of disclosure was violated through bad faith or intentional misconduct. The Office encourages applicants to carefully examine:

(1) Prior art cited in search reports of a foreign patent office in a counterpart application, and

(2) The closest information over which individuals associated with the filing or prosecution of a patent application believe any pending claim patentably defines, to make sure that any material information contained therein is disclosed to the Office.

(b) Information is but-for material to patentability if the Office would not allow a claim if the Office were aware of the information, applying the preponderance of the evidence standard and giving the claim its broadest reasonable construction consistent with the specification.

Rule 555(a) includes substantially similar language but removes the "patents and printed publications" limitation of the previous version of 555(a) to encompass disclosure of information as to any matter that is appropriate for consideration in a reexamination proceeding (e.g.,admissions by patent owner), as opposed to being limited to patents and printed publications.

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